Romidepsin
Histone Deacetylase (Hdac) Inhibitors
Sold as ISTODAX
- Drug class
- Histone Deacetylase (Hdac) Inhibitors
- Availability
- Prescription only
- Routes
- Intravenous
- Markets covered
- 2
- Products on record
- 2
- FDA reports (12 mo)
- 49
Overview
Plain-language summary, compiled from the cited regulatory records
Romidepsin is a medication classified as a Histone Deacetylase (HDAC) inhibitor [1]. It is approved for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have previously undergone at least one systemic therapy [1].
In the United States, romidepsin is marketed under the brand name ISTODAX [1]. This drug works by inhibiting histone deacetylase, an enzyme involved in regulating gene expression [1]. By targeting this enzyme, romidepsin aims to disrupt the growth and survival of cancer cells in CTCL.
Recent data indicates there were 49 adverse event reports for romidepsin in the past 12 months [2]. The most frequently reported adverse events include product storage errors, perceived drug ineffectiveness, off-label use, cytopenia, and drug intolerance [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 1 | January 31, 2023 |
| CA Canada | Health Canada | 1 | January 13, 2026 |
USUnited States· FDA
1 product
Uses
1 INDICATIONS AND USAGE ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).
How to take
CACanada· Health Canada
1 product
Uses
ISTODAX® (romidepsin for injection) is indicated for: • the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) who are not eligible for transplant and have received at least one prior systemic therapy.
Approval is based on response rates demonstrated in a single-arm trial (see 14 CLINICAL TRIALS). Improvement in overall survival has not been demonstrated with ISTODAX. The clinical benefit of ISTODAX in the relapsed/refractory PTCL setting remains unconfirmed.
ISTODAX should not be initiated in new patients outside of an investigational setting. Distribution Restriction ISTODAX is only available through the Restricted Access Program to patients currently receiving treatment with ISTODAX. Prescribers must register their patients under the Restricted Access Program to prescribe and dispense the product.
ISTODAX will be withdrawn from the Canadian Market after the last patient terminates treatment with ISTODAX. com. 1 Pediatrics Pediatrics (< 18 years of age): The safety and effectiveness of ISTODAX in pediatric patients has not been established.
Drug interactions
Known interactions involving Romidepsin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 336. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 03b39d40-90fe-11… · revised January 31, 2023 [PDF]
- [2]Health Canada (DPD) · 02414295 · revised January 13, 2026
- [3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.